Secondary hyperparathyroidism in hemodialysis patients
Conditions
Interventions
Group U: Upacicarsetona sodium hydrate (Sanwa Kagaku Kenkyusho Co., Ltd. and Kissei Pharmaceutical Industry Co. Product name: Upasita for Intravenous Dialysis) Injected three times a week into the v
Starting dose>
25 mcg per dose for pre-dialysis serum intact PTH greater than 121 pg/mL and pre-dialysis serum corrected calcium concentration less than 9.0 mg/dL
50 mcg per dose for pre-dialysis serum intact PTH greater than 121 pg/mL and pre-dialysis serum corrected calcium concentration greater than 9.0 mg/dL. <
Dose adjustment criteria>
<
Dose escalation>
If pre-dialysis serum intact PTH is greater than 241 pg/mL, the dose should be increased by 1 step starting from the day after the maximum dialysis interval based on the following 1) Current dose has
Dose Reduction>
If pre-dialysis serum intact PTH is less than 60 pg/mL, the dose should be reduced by 1 step from the next dose according to the following 1) If the pre-dialysis serum intact PTH concentration is les
Withdrawal and Resumption of Dose>
Drug should be stopped immediately in any of the following cases (1) Serum-corrected calcium concentration becomes less than 7.5 mg/dL (2) When the investigator determines that a dose reduction is n
Sponsors
others
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who have given written consent to participate in the study. (2) Men and women at least 18 years of age at the time of consent. (3) Patients undergoing hemodialysis or hemodiafiltration three times a week on the day of the screening test conducted between 4 weeks and 1 week before the start of treatment. (4) Patients with pre-dialysis serum intact PTH greater than 121 pg/mL and pre-dialysis serum corrected calcium concentration greater than 8.4 mg/dL after the maximum dialysis day interval at the time of the screening test.
Exclusion criteria
Exclusion criteria: (1) Patients with primary hyperparathyroidism. (2) Patients with pre-dialysis serum intact PTH less than 121 pg/mL and pre-dialysis serum corrected calcium concentration less than 8.4 mg/dL after the maximum dialysis day interval at the time of screening after 8 weeks of withdrawal period established after the screening test. (3) Who has changed the dosage or administration of calcimimetics within 4 weeks before the screening test (including new dosage) (4) Who is using or has used the following drugs within the respective periods before the screening test Within 4 weeks: Parathyroid hormone preparations, calcium-containing phosphorus adsorbents Within 12 weeks: Bisphosphonates Within 24 weeks: RANKL inhibitors (5) Who used parathyroid hormone, bisphosphonate, and RANKL inhibitors (6) Patients with a new history of any of the following within 12 weeks before screening. Parathyroid intervention, bone fracture, myocardial infarction, stroke, lower limb amputation, coronary artery or lower limb revascularization, respiratory failure with resting SpO2 < 90%. (7) Critically ill patients who are judged to have a life expectancy of 1 year or less. (8) Patients with malignant tumors, were diagnosed within the past 5 years at the time of obtaining consent. (9) Granulomatous disease (10) Liver dysfunction (11) Patients on peritoneal dialysis (including combined use with hemodialysis). (12) Pregnant women, lactating women, or women who wish to become pregnant within one year. (13) With allergy to upacalcet and etelcalcetide. (14) Who has changed the dialysis method, dialyzer, dialysate, dialysis time, blood flow rate, or dialysate flow rate within 2 weeks before the screening test (15) Patient on dialysate with a dialysate calcium concentration of less than 2.5 mEq/L (16) With a history or family history of congenital QT prolongation syndrome. (17) Who is considered inappropriate for inclusion in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weekly doses of vitamin D preparations every 4 weeks after the start of calcimimetics administration and the change from the start of calcimimetics administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients achieving management targets for corrected Ca, P, and intact PTH every 4 weeks after initiation of treatment. Time to achieve pre-dialysis serum intact PTH concentrations of 60-240 pg/mL, the control target. Percentage of patients with intact PTH 30% reduction every 4 weeks after initiation of treatment. | — |
Countries
Japan
Contacts
Public ContactYuuta Hara
Social medical corporation Kenwakai, Kenwakai Hospital. Nephrology
Outcome results
None listed